LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-...

FDA Device Recall #Z-1242-2015 — Class II — February 25, 2015

Recall Summary

Recall Number Z-1242-2015
Classification Class II — Moderate risk
Date Initiated February 25, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Biosense Webster, Inc.
Location Irwindale, CA
Product Type Devices
Quantity 464 units

Product Description

LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

Reason for Recall

Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

All lots manufactured as of February 24, 2015 are affected.

Other Recalls from Biosense Webster, Inc.

Recall # Classification Product Date
Z-1205-2025 Class I VARIPULSE Bi-Directional Ablation Catheter REF... Jan 5, 2025
Z-1290-2024 Class II CARTO VIZIGO Bi-Directional Guiding Sheath, RE... Feb 16, 2024
Z-1320-2023 Class II Biosense Webster Carto Vizigo Bi-Directional Gu... Feb 21, 2023
Z-1319-2023 Class II Biosense Webster Carto Vizigo Bi-Directional Gu... Feb 21, 2023
Z-1677-2022 Class II CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath... Jun 29, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.